In a medical landscape where just a fraction of clinical trial participants are diverse in their race, sex, lifestyle or genetics, a team of physicians have published a paper detailing how their peers can ramp up efforts to recruit a more representative pool of patients.
More than half of the U.S. population is projected to be non-white by 2045, Luther T. Clark, MD, and colleagues wrote in Current Problems in Cardiology—yet in 2011, just 5 percent and 1 percent of clinical trial participants were black or Hispanic, respectively.
“Lack of diversity in clinical trials is a moral, scientific and medical issue,” Clark and coauthors said. “When trial participants are homogenous, findings may be skewed and result in a body of clinical knowledge that is not generalizable. However, while general scientific knowledge and medical care have advanced substantially in recent years, African Americans, Hispanics and other U.S. minority groups have benefited less from those advances than their white counterparts.”
The researchers embarked on an eight-step process involving a literature review, expert interviews and in-depth analyses to identify and test a series of potentially sustainable solutions to the issue. This is their advice to their colleagues.
1. Work on building trust.
A lack of trust in the healthcare system and research community was the No. 1 reason Clark et al. identified for the paucity of diverse faces in clinical trials. To mitigate the anxiety of “being a guinea pig,” the authors recommended forging partnerships with community groups, like local medical providers, leaders and faith-based communities “in a manner that is effective, transparent and culturally appropriate.”
They also suggested including family members or close friends in the decision-making process and reminding patients that their health will be closely monitored and prioritized during the study. In a recent report, the American Cancer Society recommended using input from past participants to better construct patient-centric trials people feel more comfortable with.
2. Offer appropriate support and compensation.
Clark and colleagues said difficult inconveniences—like insufficient insurance coverage, unreliable transportation and a lack of technology or time—also bar a fair number of minorities from participating in clinical trials, even though sponsors or insurers generally cover the costs associated with such projects.
The authors recommended providing transportation for patients, catering more to their schedules, paying them appropriately and providing mobile support, like a cellphone or laptop when needed, to help patients feel more comfortable participating in trials.
“Identification of the benefits of technology reinforces current trends and opportunities provided by the increasing use of mobile technology and social media platforms,” they wrote. “Addressing patients’ logistical and financial challenges may not only increase the likelihood of participation but also may increase satisfaction and improve the overall experience of research participation.”
3. Educate staff to educate the public.
“Increasing awareness during the precontemplation and contemplation stages of behavioral change helps set the context for further stages of change and likely will increase clinical trial participation,” Clark and coauthors wrote—but a lack of awareness and understanding of clinical trials are major barriers to participation.
The team said results from their study underline the importance of increasing awareness of trials and their implications, though they acknowledge it’s easier said than done. They recommended a patient’s primary care physician, as well as key stakeholders like clinical trial teams, investigators, coordinators and sponsors, should be well-versed in the clinical research process and be ready to explain that process to patients.
“Racial designation in the U.S. is primarily a social rather than biological construct and is a poor proxy for genetics,” the authors wrote. “However, differences in health outcomes based on race and ethnicity are real and have been extensively documented. To ensure that medical discoveries, new treatments and interventions are applicable to all populations for whom they are intended, appropriately representative clinical trial diversity is a moral, scientific and medical imperative.”